Cryobiopsy for diagnosing mediastinal conditions in Sweden
Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden
This study is testing a new biopsy method to see if it helps doctors better diagnose lung and chest conditions like cancer and infections in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 2 sites (Lund and 1 other locations) |
| Trial ID | NCT06347939 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of Endobronchial UltraSound TransBronchial Mediastinal CryoBiopsy (EBUS TBMCB) in diagnosing mediastinal lymphadenopathy, lung cancer, sarcoidosis, lymphoma, and tuberculosis. Participants will undergo EBUS TBNA and EBUS TBMCB procedures, with their biopsy samples compared to assess the diagnostic yield of each method. The study aims to determine how many biopsies are necessary to achieve a definitive diagnosis and to evaluate the added value of combining EBUS TBMCB with EBUS TBNA. Follow-up assessments will occur four weeks post-procedure to monitor for any complications.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with mediastinal lymphadenopathy greater than 1 cm who require sampling for diagnosis.
Not a fit: Patients with severe health conditions such as respiratory failure or high bleeding risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve diagnostic accuracy for patients with mediastinal conditions, leading to better-targeted treatments.
How similar studies have performed: Previous studies have shown promising results for EBUS TBMCB, indicating its potential effectiveness in improving diagnostic yield.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mediastinal lymphadenopathy with a diameter greater than 1 cm. * Indication for assessment and sampling according to clinical praxis * Age \> 18 years * Patients consent to participate in the study. Exclusion Criteria: * Hemodynamically instable patient * Myocardial infarction in the last six weeks prior to participating in the study. * Life threatening arrythmia * Respiratory failure and inadequate blood oxygenation despite oxygen supply. * Tracheal obstruction of high grade. * High bleeding risk * Patient not willing to participate in the study * Patient not speaking swedish and needing translator during the procedure
Where this trial is running
Lund and 1 other locations
- Respiratory medicine and allergy department, Skåne University Hospital — Lund, Sweden (Recruiting)
- Norrlands universitetssjukhus — Umeå, Sweden (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.